MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Microbial Contamination of Device (2303)

Patient Problem Sepsis (2067)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

After the subject device was reprocessed at the olympus (b)(4), the subject device was returned to olympus (b)(4) for evaluation.It was confirmed that some scratches were found on the light guide lens, and wear and tear on the bending rubber of the subject device.As a result of the culture test on the subject device that (b)(4) ordered an independent laboratory, no microorganism was detected.An olympus service representative observed the user facility¿s reprocessing procedure with no reprocessing deviations noted.The exact cause could not be determined at present.If significant additional information is received later, a supplemental report will be submitted.This is report 1 of 5.

Event Description

Olympus medical systems corp.(omsc) was informed that five patients were admitted with urosepsis after having undergone the procedure by the subject device.Pseudomonas was detected in two patients of the five.It is unknown whether the bacteria were detected in the remaining three patients of the five.As a result of the culture test on the subject device performed by the facility, pseudomonas was detected from the instrument channel of the subject device.

Manufacturer Narrative

Olympus (b)(4) reported on december 5, 2016 that microorganisms were detected from a 3 way-tap and no microorganism was detected from the subject device.Olympus medical systems corp (omsc) will collect information of the 3-way tap.If significant additional information is received at a later time, a supplemental report will be followed.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6131236
• MDR Text Key: 60993585
• Report Number: 8010047-2016-10074
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other